Reference Number: JO-2003-447916
Snr Regulatory Affairs Associate
Job Type: Contract
Senior Regulatory Affairs Associate CMC
Length: 12-month contract
Location: Currently remote working, long term opportunity to work from either London or Cambridge site
Rate: Offering up to 30.00 Per Hour DOE
Regulatory Professionals is collaborating with a international recognised pharmaceutical firm who are seeking a highly motivated, self-driven and enthusiastic Senior Regulatory Affairs professional to join their international CMC team on a 12 month contract basis. Working under the direction of the Regulatory Lead you will assist in the compilation of CMC regulatory packages for submission.
The ideal individual will have strong CMC full lifecycle background, with prior experience with new Market Authorisations and variations.
Job Responsibilities include;
Collect and / or create country specific documents for regulatory filings worldwide.
Compile and maintain CTA/MA documentation (e.g. variations, substantial amendments) in collaboration with Regional Regulatory Lead.
Ensure compliance via timely submissions to regulatory agencies.
Coordinate collection of functional documents in support of regulatory applications.
As appropriate support execution of regulatory strategy.
Candidate Requirements include;
Must be eligible to live and work in the UK
Life Sciences degree
A minimum of 2 years Regulatory Affairs experience
Understanding of drug development process
Knowledge and understanding of CMC requirements, especially country specific documents for international filings
If this position is of interest to your please call Sophie at Regulatory Professionals on 07526 003 117 or forward your up to date CV to firstname.lastname@example.org.